The Affordable Care Act created some desperately needed means to start controlling ever-rising health care costs. Many — like preventive care or delivery reforms — will take some time to realize savings. In contrast, new anti-fraud efforts look to be paying off right away, in amounts much bigger than expected.

The health reform law provided $350 million over ten years to increase anti-fraud investigation and enforcement resources for the Department of Justice (DOJ) and State Attorneys-General. The goal? Saving $6.4 billion over the next decade. Given that some estimate that fraud and waste cost as much as $60 billion a year, or $600 billion over a decade, saving one percent of that amount seems a pretty modest impact.

But wait! New estimates project that current or pending settlements of drug fraud litigation by the DOJ and the Attorneys-General will top $8 billion in FY2012 alone, according to the group Taxpayers Against Fraud. (See their list below.) This is not the culmination of hundreds of lawsuits; it’s just the eight biggest. So it looks like this anti-fraud effort under the ACA will meet and then surpass this ten-year goal in less than two years!

To be fair, some of these fraud investigations were undoubtedly underway before the increased funding for anti-fraud efforts reached the DOJ and State Attorneys-General offices. But there is little doubt that providing these over-worked regulators with increased resources was a big help in increasing enforcement. DOJ probably has fewer lawyers working on all their pending drug fraud cases than some of the biggest drugmakers hire to defend in just one lawsuit. But despite these disparities, the results show that very modest government investment in fighting fraud, coupled with hard work by government lawyers and whistleblowers, can pay off big.

For example, earlier this week drugmaker Abbott Labs in Chicago settled a civil and criminal investigation of their illegal promotion of the anti-convulsant drug Depakote as an unapproved treatment of dementia in seniors, and of various conditions in children. Abbott pleaded guilty to promoting these unapproved, or ‘off-label’ uses of Depakote, and agreed to pay $1.6 billion – one of the biggest settlements for the illegal promotion of a single drug.

There could be a couple hundred pending whistle-blower lawsuits that are filed under seal and being investigated now by the federal or state regulators. These pending lawsuits may add up to billions of dollars of additional settlements.

Some critics have warned that even billion-dollar fines are an inadequate deterrent when a drug company can profit far more on illegal sales of a drug.

For instance, the $1.2 billion record-breaking settlement with Eli Lilly in 2009 for illegal promotion of their antipsychotic drug Zeprexa was less than 5 percent of Lilly’s gross sales. Yet eight months later, DOJ shattered this record with an even bigger $2.3 billion settlement with Pfizer, which amounted to 14 percent of their gross sales of eight illegally marketed drugs.

Similarly, this month’s $1.6 billion Depakote settlement is nearly 12 percent of the drug’s $13.8 billion in gross sales revenue from 1998 to 2008. Furthermore, DOJ is pioneering two mechanisms to deter future illegal conduct by Abbott, along with this hefty fine.

First, the Depakote settlement places Abbott on probation and imposes a corporate compliance and monitoring program, for five years. If Abbott violates the compliance agreement or significantly violates the law, the government can exclude Abbott, and all their drug products, from federal health care programs. That would cost Abbott billions in lost sales on numerous drugs.

The settlement also aims to hold Abbott’s corporate leadership accountable. Abbott’s CEO must personally certify compliance and the board of directors must review and report on compliance each year. If the CEO or board is lax in these duties, they could be excluded from their positions at Abbott. And if they intentionally lie to the government to cover up any misconduct, they could face personal criminal liability under the federal False Statements Statute.

Sadly, Abbott’s illegal promotion of ineffective and dangerous uses of Depakote has both harmed and put at risk what is arguably the most vulnerable patient population – seniors suffering from dementia, who live away from their families in nursing homes. Undoubtedly millions of seniors were and continue to be given Depakote inappropriately as a result of Abbott’s illegal promotional campaign.

More to come on (1) actions that Medicare and Medicaid can take to address the continuing effects on patients of illegal promotions of off-label use of drugs and (2) how the Arkansas AG fought prescription drug fraud, winning huge fines to plug the state’s Medicaid budget deficit. This blog was also posted on Health Policy Hub.

– Wells Wilkinson, Director, Prescription Access Litigation
Staff Attorney, Community Catalyst

Projected Drug Fraud Settlements in FY 2012

A new report suggests that despite the economic downturn, the pharmaceutical and medical device sectors in Minnesota have experienced significant growth in recent years, mirroring similar expansion in Massachusetts. These data further drain much-repeated claims that pharma and device disclosure and gift laws passed in those states would have a “chilling effect” on industry—claims that last year worked to squelch an update to Minnesota’s law that would have required medical device companies to report payments made to health care providers in that state, as well.

The report, by the BioBusiness Alliance of Minnesota, found 20 percent growth in the state’s biobusiness jobs between 2002-2007, and within that trend, pharma jobs stood out, growing 76 percent, more than the 10 other states analyzed in the report. “Employment in the medical device industry in Minnesota increased by 4,500 jobs during 2002 to 2007,” the Minnesota Star Tribune underscored, “compared with a loss of 11,000 medical device jobs nationwide during that same time period.”

And last week brought more good news for the pharma industry in Massachusetts: Pfizer’s bringing hundreds more jobs to the Boston area, and looking to relocate two plants there from Connecticut. As you may know, since passing a first-of-its-kind gift restrictions and payment disclosure law in 2008, Massachusetts has been the epicenter of the most heated debate about the effect of state transparency regs on business. But headline after headline like this one in the years since the law passed suggest that, if anything, pharma business in the Bay State is stronger than maybe any other North American hub, and with the help of the state’s life sciences initiative, companies keep moving in and spreading out.

Here’s the Globe:

“Pfizer’s decision to increase research in the Boston area follows similar recent moves by global drug makers such as Novartis AG of Switzerland and Sanofi-Aventis SA of France, which want to plug into the area’s life sciences industry at a time when drug discovery has slowed worldwide…

‘It’s a confirmation that, when some of these companies have to make tough decisions, they continue to favor Massachusetts,’ said Susan Windham-Bannister, president of the Massachusetts Life Sciences Center, a state agency created to implement Governor Deval Patrick’s life sciences initiative. ‘It’s a good place to partner, it’s a good place to keep the finger on the pulse, and it’s a good place to tap into a skilled workforce.’’’

–Kate Petersen, PostScript blogger

An investigative outfit’s consolidation and analysis of payments that drug companies made to doctors has refocused attention on state efforts to shine light on the financial ties between doctors and drugmakers.

Currently three states—Minnesota, Massachusetts, and Vermont—require drug companies to disclose payments to prescribers and make some of that data public. While each of these states takes a different approach to collecting and making the payment data available to the public (more on that here), information from all three have been extremely valuable in demonstrating the dimensions and scope of these marketing relationships. And now a new value to the state data has emerged: demonstrating that pharma isn’t keeping very good track of who it’s been paying what.

The ProPublica report in Monday’s Minnesota Star Tribune and here online found a series of big discrepancies between what a company said it paid a doctor on its website and what it told the state of Minnesota it paid the same person. Right now, ProPublica can only crosscheck the seven companies that have posted payments on their own websites.

Big pharma has been caught off-guard again. Like the reports earlier this fall that hundreds of sanctioned doctors were still making cash on the side with speaking gigs, some companies seem not to know who they are paying what. Despite spending billions of dollars to develop and manufacture drugs, and spending other billions to market them to prescribers and armchair prescribers (i.e. consumers), the folks who brought you Lipitor, Effexor, Zyprexa and that one that will send this to your spam folder, don’t seem to know what they paid docs to give PowerPoint presentations.

The report also gave some doctors the opportunity to say strange things:

Dr. Randy Shapiro, one of the doctors whose take was under-reported to Minnesota told ProPublica that if anything, patients should want to see their physician among the speakers on these payment lists. “If their doctor is not on the list,” he said, “maybe they should look for a different doctor.”

That’s…an interesting take. We’re not aware of any links between participation on speakers bureaus and clinical excellence or bedside manner. Based on some earlier findings (we’re thinking of the Risperdal, Biederman, and all these folks) we’re not sure that would be our prescription. (In fact, based on the mounds of evidence about the influence of even small gifts, we tend to think finding a pharm-free physician or one who is engaged on clinical projects she’s happy to tell you about, and not just the PowerPoint circuit, is the way to go).

And the top-paid physician in Minnesota, Dr. Todd Hess, a pain specialist in St. Paul who made over $364,000 last year, told ProPublica that the media is unfairly lumping these educational talks with the old pharma ways.

“This is a mountain-molehill thing,” Hess told ProPublica. “I know the problems of the past. I know what pharma has done to change those. People just can’t get over the past.”

Maybe he knows something that we don’t know, but it might not be a problem of a press corps with a too-long memory. Recently, awkward chuckles went up through the pharma news sphere when word of Abbott’s celebratory pig roast for a Maryland doc who managed to implant 30 stents in one day showed up in a Senate Finance report.

That wasn’t back in the high-flying, anything-goes 90s depicted in the recent pharma-flick “Love and Other Drugs.” It was two years ago. Teachers are warned not to grade 30 papers in one day (and this blogger can vouch for that advice). We’re pretty sure, like the Senate Finance Committee, that 30 stent operations in a day is an even worse idea.

Despite what headlined docs and pharma spokespeople say, there is still a lot of money changing hands for things of questionable clinical value. The thing about the ProPublica data is: it’s current. The stories about hundreds of millions of dollars going to sanctioned docs, the Massachusetts reports that just came out–those payments are all from 2009-present. And now we see it isn’t being recorded very well. Maybe some of these companies really did believe no one would bother to look.

“If all the reports are true I’m outraged,” Maryland delegate and physician Dan Morhaim told the Baltimore Sun.

According to the Sun, “Maryland’s General Assembly has explored limiting financial relationships between doctors and drug or device makers, but no laws have come from it,” but Morhaim said ‘it’s a continuing topic of interest’ in the next legislative session.”

While there are real and beneficial relationships between academic medicine and industry, Pew Prescription Project Allan Coukell told a Memphis paper this week that “patients deserve to know if their doctors are receiving money from drug companies.”

And patients and state lawmakers are right to be concerned about what add up to significant financial exchanges between industry and doctors willing to pitch drugs to their colleagues. We wouldn’t be surprised to see more states explore ways to keep track of or limit the types of payments industry makes to doctors. Regardless, pharma should take this opportunity to get its house in order so everyone’s on the same—accurate—reporting page by the time Physician Payments Sunshine kicks in.

–Kate Petersen, PostScript blogger

Having revealed that more than 250 physicians with serious sanctions against their medical licenses are on the speaking circuit of some of the nation’s top drug companies, ProPublica and a series of news outlets around the country have put the question to the companies: When it comes to speakers bureaus, who’s keeping the gate?

One company said that they had a previous plan for gatekeeping.  So what happened to it?

These are not nitpicky violations we’re talking about—a CME credit here or there, unpaid dues. One doctor listed in the ProPublica database, Kenneth Fisher, is paid by GlaxoSmithKline and two other companies despite having been on probation for nine years in the state of Arizona for a series of serious misconduct charges, including sexually violating HIV patients.

This is the sort of thing that makes landlords do background checks. And if landlords can do them, why not drug companies spending millions to have certain doctors talk about their finely-tuned brands?

“Let’s be honest, they do a lot of very complicated things very well,” Hastings Center bioethicist Josephine Johnston told ProPublica. “These are the people who have figured out how to get prescription data for individual doctors so they can send drug reps to target particular doctors in particular ways.”

Good point. Data-mining isn’t exactly a simple (or transparent) marketing strategy, but the industry has it down, spending millions each year to buy individual prescriber records and pairing them with prescribers’ names so that they can tell how much Lipitor Dr. Doe is writing, and how many more scrips she’s likely to write (more on data-mining here). But complicated things in service of marketing that works, and complicated things that might make effective marketing harder are two different matters (although one wonders if there aren’t easily 250+ blemish-free docs willing to step in to fill vacancies on the speaking circuit).

Perhaps the failure to do background checks—the casualness it conveys—underscores just how big these marketing budgets are. That the $7.1 million these seven companies gave the sanctioned docs in the last two years isn’t enough to inspire thorough background checks suggests the sums don’t make industry’s reputation radar. Pharma has been cutting sales rep jobs for awhile now, but let’s not mistake that for cutting marketing spending—doctor-to-doctor talks work, and they are still going strong: The ProPublica aggregator totaled up $282 million in speaking fees from seven companies between 2009 and 2010.  And there are more than 70 drug companies in marketing in the U.S., meaning there’s potentially a lot more money on the table that we will learn of when state disclosure laws and the federal Sunshine laws kick into effect.

None of the seven companies whose payment data was reported offered an official to speak with ProPublica (a sign as a reporter that you’re on to something). But among the general statements they did make, we couldn’t help our jaw from dropping a little as we read the range of reasons companies gave for not doing background checks on their speakers:

Pfizer and Glaxo noted that some of the physicians listed no longer speak for them.

Pfizer also noted that none of its doctors had been banned from participating in federal health programs.

Merck & Co. said it had “previously initiated” plans to conduct more frequent background checks and “is exploring additional capabilities.” The firm would not be more specific.

Johnson & Johnson, Glaxo and Cephalon each said that they are always looking for ways to enhance their selection of speakers.

In an e-mail, Glaxo spokesman Kevin Colgan added that disciplinary actions alone shouldn’t be the basis for excluding a potential speaker or consultant.”

Glaxo and Lilly each made payments to more than 100 of the 292 sanctioned docs ProPublica identified.

After reading about Dr. Fisher’s record, we’d be interested to see the criteria GSK does use to exclude a potential speaker or consultant.

–Kate Petersen, PostScript blogger

Want to find out about drug recalls when they happen? It seems FDA may need to get more involved. That may be one lesson to take from last week’s announcement that in August, Pfizer recalled 191,000 bottles of Lipitor after several patients reported a musty odor. Though it’s link to the Lipitor complaints is yet unconfirmed, a Pfizer test revealed low levels of 2,4,6 tribromoanisole in one of the lots, the same chemical used to coat wood shipping pallets that was linked to the delayed recall of millions of bottles of J&J’s Tylenol last winter.

Under current rules, companies that recall medications do not have to tell the FDA about a recall at all, much less within a certain timeframe. Though companies are required to notify the agency of chemical or physical changes, deterioration or contamination, J&J’s delayed recall and FDA notification (the company started receiving consumer complaints of musty odors in early 2008) suggests that even that reporting rule may be broadly, or loosely, interpreted by companies.

Pfizer has indicated that the recalled bottles of its blockbuster cholesterol medication came from a third-party supplier, but would not name the supplier or its location. A spokesman for the company told in-pharma Technologist that it is working with the FDA to “[change] the way that the bottles are packaged at the bottle supplier, decreasing time to delivery, and relocating some bottle production to other facilities operated by the supplier.”

Without sounding like a broken record (or an iPod on repeat), the amount of irregular, voluntary, and sometimes significantly delayed public notice of drugs pulled from the market is stacking up faster than it should, at least for the comfort of those on the public side of the equation.  Drugmakers’ conflict of interest – that is, a fear of potential sales lost by telling the public the full and timely facts about why, where, and when a drug was recalled – may be just too great to overcome with cautionary tales and promises at Congressional hearings to do better.

The FDA, free of that conflict and charged first with protecting the public’s health, is a fundamentally better steward of a recall, setting requirements for timeliness and disclosure, and overseeing–not just reactively advising–a company on when and how to remove risky drugs from the shelves. Several bills before Congress would give FDA that authority, and the Lipitor recall joins the list of reasons to give them consideration.

For more, see PostScript’s drug safety archive.

Speaking of more rapid responses, consider following “SafeRxWatch,” Community Catalyst’s new Facebook page and Twitter feed on drug safety issues.

–Kate Petersen, PostScript blogger

Are the muckrakers moving more slowly than their subjects in the medical field when it comes to pharmaceutical conflicts of interest? That’s one way to look at two recent stories that indicate that the press establishment may be increasingly confronted with the same questions that it’s been pressing physician and medical groups to answer for years.

Eyebrows were raised recently over the news that Pfizer endowed $80,000 worth of fellowships through the National Press Foundation for 15 journalists to attend a four-day conference on cancer in October. According to Pharmalot, this is the second year of the conference.

On her blog at Politics Daily, Alison Fairbrother asks: Just how big a conflict is this?

Well, plenty of people (journalists included) readily answered: Big. Pfizer makes a handful of incredibly expensive cancer drugs. (Probably not on the conference program is Forbes columnist Robert Langreth’s “Why Pfizer can’t cure cancer.”) There is now wide consensus that industry-backed education for doctors (CME) creates the potential for bias, and many medical schools, specialty societies and physicians groups have moved accordingly, restricting ways that industry can support CME or banning such support entirely, as the University of Michigan did earlier this year.

This week, in fact, a Harvard neurologist launched an industry-free CME company that will draw on expertise of non-conflicted Harvard physicians to create the curriculum modules. It’s encouraging to see the move toward industry-free continuing medical education move beyond regulation and back into the private market.

And as for the journalists? A Pfizer spokesman told Pharmalot this:  “With the 24/7 news cycle now, my concern continues to be the ability of journalists to have enough time to understand the material and have the knowledge to do the analytic work they need to do. I can complain or be part of the solution. We believe we’re doing this the right way.”

That’s not surprising. And it sounds a whole lot like the pharma industry’s pitch for detailing and CME sponsorship: How else, they say, are busy doctors going to get this information?

Well, there are beginning to be more alternatives for doctors. And we would posit that that’s precisely journalists’ job: to figure out the right unbiased way to get the information, also known as reporting. That’s what they are: professional information-getters.

But as newsrooms cut and cut further, they will be scanning ever-wider circles for someone willing to foot the bill, as Gary Schwitzer of Health News Review told Pharmalot and Fairbrother.  And pharmaceutical companies are great at footing the bill, especially when the ROI looks good.

And when you have the President of the National Press Foundation saying things like this—“I evolved a way of using a strict set of guidelines which basically say we’ll take money from anybody as long as they follow certain rules”—how could pharmaceutical companies not see an open door? They have whole divisions devoted to following rules.

Arguably, awareness of the potentially problematic financial ties between physicians and industry has never been higher, and the new federal Physician Payments Sunshine law will further illuminate the scope and prevalence of those ties. It’s perhaps ironic, then, that the industry that played such a big role in raising that awareness may be next to confront its own vulnerability to Rx influence.

–Kate Petersen, PostScript blogger

Last week the Association of American Medical Colleges and three other university associations took aim at the NIH’s proposed rule to tighten disclosure and reporting requirements, departing from their initial support of tightened regs last summer.

Like the AAMC and Association of American Universities (AAU), who joined AAMC in its comments, we voiced our support for reform and suggested ways to strengthen reporting and transparency when the NIH solicited public comment last summer on ways to shore up rules aimed at promoting objectivity in research.

This May, the Institutes issued a proposed rule with many strong reforms (you can read about that here on PostScript.) The rule was amended and the comment period extended after it came to light that an National Institutes for Mental Health director Thomas Insel had recommended psychiatrist Charles Nemeroff for a job at University of Miami, despite Nemeroff’s failure to report large sums he received from GlaxoSmithKline while working on an NIH–backed grant on a GSK drug. That violated NIH rules and led to his resignation from Emory University, but Insel apparently assured Miami administrators that Nemeroff would be eligible for NIH funds at a different university. (Carlat Psychiatry Blog and Pharmalot have the backstory.)

In its newest comments, AAMC asks for reporting exclusions that would significantly weaken the proposal.  As currently written, NIH would exempt disclosures only for seminars at institutes of higher ed and government agencies. AAMC suggests exempting all speaking gigs, lectures and seminars at academic teaching hospitals, medical centers, research institutes affiliated with an institute of higher education, and other non-profits involved in research.

They also suggest that travel funds be exempted from reporting requirements, as well as any funding for CME presentations that meet ACCME standards. However, in this compliance-savvy climate, most industry-backed CME presentations in which NIH investigators participate are ACCME accredited – and such accreditation does not eliminate inherent bias in such programs.

Unfortunately, those are pretty big slices of the pie. A lot of research-related dollars are flowing through third parties at this point—including the non-profits and other third parties that AAMC asks to be exempted. Most patient organizations and professional medical associations are non-profits, and the grants money they receive is often passed on to individuals for fellowships, participation in research symposia, or education. As you can see on Pfizer and Lilly’s websites, most grant recipients from the two drug companies listed here are non-profits, and many of those grants seem to be for these research-related purposes.  
Just because they are issued through a non-profit does not mean these funds cannot somehow influence how an investigator conducts his research.

The AAMC and its cosigners also suggest that NIH should rely first on investigators to decide what to report, based on their judgment of the relatedness of a financial interest to their research.

Well, this is how much of this started – Sen. Grassley and others found that investigators, who decide under current regs what they do and don’t report to their institution, weren’t reporting some pretty big industry payments related to their research. See Nemeroff, Schatzberg, Biederman, et al. In most cases, the medical schools that AAMC represents were the ones to get the bad press and in hot water for these omissions. The NIH proposed rule change would help protect these institutions by taking the evaluative reporting decision away from the investigator. With the Sunshine Act providing a national database of company payments to physicians and teaching hospitals, we don’t want institutions that are accountable to NIH to be caught out if they aren’t aware of a payment to an investigator that shows up in the Sunshine database.

The AAMC also proposes that if undisclosed conduct is discovered, an investigation could be waived.  But we support NIH’s proposed mandatory investigation if someone fails to report a Financial Conflict of Interest (FCOI). The new regs were proposed and will be implemented for good reason. There is no current mechanism for NIH or an institution to judge whether an investigator failed to report a FCOI “in bad faith” or whether the unreported interest affected research. Unless you investigate, there is almost no way to uncover intentional and problematic non-disclosures. We can’t count on whistleblowers to enforce this.

Worryingly, the groups frame their comments by calling into question the very need for the reforms.

There is a paucity of evidence that the disclosure and management of financial conflicts of interest affect objectivity and integrity. In the absence of such evidence, onerous regulations are not only unwarranted, but could create a glut of policies that increase activity without adding protections and at the same time erode the trust between the regulators and those being regulated.

We think this is a tough claim to make, since the rule was proposed and amended in large part because of Congressional investigations and media stories that revealed millions of dollars of undisclosed industry funds in the hands of publicly-funded researchers.

While there may be no study yet that links disclosure of FCOIs to research integrity, there is increasing evidence of bias in research and disclosure is one step we can take to try to reduce this bias.

–Kate Petersen and Ian Reynolds, PostScript

The launch of drug giant Pfizer’s database of payments to doctors and medical groups this week has shone some more light on the Physician Payments Sunshine Act, which passed last week with the comprehensive health reform bill. The company website, mandated in a court order as part of an illegal marketing settlement last year, showed that the company paid doctors $35 million in the last half of 2009–$20 million of it for consulting and promotional speaking.

The Sunshine act, as you recall, requires drug companies to report payments over $10 to physicians and teaching hospitals into a national public website. Such reports will begin in 2013. Allan Coukell, director of the Pew Prescription project, a key backer of the Sunshine Act over the last three years, talked to news organizations about the importance of transparency and the limited usefulness of company websites such as Pfizer’s to the public’s understanding of to the public.

“Separate company databases, while welcome, are still short of what we need, which is a single national database,” Coukell told the Wall Street Journal.

We wrote earlier on PostScript about the pros and cons of current company databases.

And University of Miami announced this week its own searchable database of drug company payments to faculty, joining a handful of other academic medical centers that have set up voluntary disclosure sites over the last several years.

“This is a growing trend,” Coukell told the Miami Herald. “I know of four other schools that are doing this. With the passage of the Sunshine Act, there’s going to be a lot, lot more.”

It’s in all the news that’s fit to print, and then some.

Read more in:

Associated Press

The New York Times

The Wall Street Journal

PBS Nightly Business Report

Science (subscription required)

–Kate Petersen, PostScript blogger

Massachusetts reached a significant milestone today in the effort to both measure and manage the extent of pharmaceutical and medical device marketing to prescribers.  The state’s Public Health Council today passed strong regulations that limit gifts and payments to prescribers, and disclose others, completing the  state’s enforceable code of conduct passed last summer.  The code, required to be at least as strong as the PhRMA and AdvaMed voluntary codes, is arguably the strongest in the nation; Minnesota’s first-in-nation gift ban does not apply to medical device companies; Massachusetts’ does. And unlike Minnesota’s standing law, the disclosure info will be posted on a public and easily-searchable database for consumers and researchers.

Among the highlights of the final regulations:

-DPH included trainees in the ban on direct payments for scholarships, CME, and other travel payments. This is a good news for the state of unbiased medical education at Massachusetts many academic medical centers.

-The Council had a good debate on prescription drug samples, and will do further study of the issue of samples as marketing tools and revisit the issue next year.

-DPH interpreted the $50 limit as a floor, meaning gifts under $50 not expressly banned in the law would not have to be disclosed. Since pens, pads, and tchotchkes are banned, this means that a lot of in-office drug lunches will fly under the radar.

-Bona fide payments to investigators for research will not have to be disclosed, but those payments for trials with marketing purposes, such as seeding trials, must be.

Seeding trials, if you’ll recall, are clinical trials whose scientific purpose is tenuous at best: “a marketing trial with a marketing objective,” in the words of the authors of a paper on the Vioxx ADVANTAGE seeding trial. Unlike other, scientifically rigorous clinical trials, seeding trials are primarily designed and carried out by marketing departments with the goal to get doctors to start using their drugs — kind of like beta-testing for gadgets and computer programs, or the little bags of free granola that come wrapped in the Sunday paper. Except with powerful, sometimes lethal pharmaceuticals.

An Internal Merck slide outlined the lead role of Merck’s marketing department in the ADVANTAGE trial:
•    Design protocol and oversee execution of trial
•    Select investigator sites
•    Run investigator meetings
•    Choose and manage CRO
•    Perform data analyses
•    Prepare publications

Historically, drug companies have not been upfront about what a clinically valuable trial and what is a seeding one – after all, what doctor or patient would sign up for a clinical trial that she knew was designed only to create product loyalty? The Council showed a good understanding of the complexity of the issue, and made it clear it that DPH and the Attorney General’s office will be actively seeking signs of such illegitimate trials and sanction companies that don’t disclose them.  And reports today of a Massachusetts-based investigator who fraudulently published 21 clinical trials on the use of painkillers like Celebrex for post-operative pain – studies funded by Pfizer – highlights anew the public interest in knowing a clinical trial’s legitimacy and money trail.

Requiring companies to report all research payments is the failsafe way to ensure such marketing-based trials are recognized and disclosed, and we would have liked to see the Council stand by that original standard. Still, we are encouraged by the Council’s recognition that the corporate marketing aims of seeding trials undermine safe and effective drugs for state residents.

As we prepare for the regs to go into effect July 1, we’ll explore, along with others, ways to identify seeding or other questionable trials in a way that is valuable to regulators who will be protecting Bay State patients by monitoring drug and device payments to doctors.

Pfizer announced today that it will begin to disclose payments made to physicians in a public online database beginning in the first half of 2010. Not only does this signal another Big (+ Wyeth = Bigger!) Pharma player hopping on the voluntary disclosure train, it would be the first company to post such information including payments to PIs of clinical trials.

Even though Pfizer is proposing a higher reporting threshold of $500, which would miss out on a healthy portion of payments like meals, the move takes more wind out of the already drooping sail of an argument the industry is hammering Massachusetts regulators with: that disclosure of clinical trial payments is Fatal to Business (especially, to hear them tell it, the Massachusetts Convention Industry).

It’s worth remembering Eli Lilly already discloses consulting and advisory payments on its website, and had pledged to widen that disclosure to match the Physician Payments Sunshine Act by 2011 (go here to read about other company promises) – so it could be said that Pfizer’s announcement is a case of the Great One-Up. But coming now – as Massachusetts Dept. of Public Health continues to come under industry fire for drafting regs that would require companies to do as Pfizer is doing – the move is significant.

As Newton’s First Law of News requires, the wires also brought this not-so-great report out of Minnesota indicating that the ethics chair and outgoing dean of the University of Minnesota Medical School, Dr. Deborah Powell, has significantly weakened recommendations by her own conflict of interest reform committee, which handed in a bold and comprehensive draft COI policy earlier this academic year.

According to the Minnesota Daily, which received a copy of the unreleased draft, “key elements of the task force’s recommendations, believed by some to be among the most needed changes, are notably absent from Powell’s draft, among them a recommendation to sever financial ties between industry and continuing medical education programs.”

Among those nips and tucks Dean Powell made to the committee’s recommendations? Yep, research:  “The task force recommended that faculty fully disclose the source of research funding as well, particularly those with clinical trials funded by industry,” but such disclosure didn’t make it into the new draft, either.

“They gutted it,” Center for Bioethics professor Carl Elliott told the Daily. Another Minnesota faculty member, Gary Schwitzer, a health journalist who has been a strong voice in calling for the separation of pharma money and faculty, told the paper he had not seen the latest draft at all, and American Medical Student Association Scorecard Director Gabriel Silverman said that the draft changes would take his read on the policies from strong to “borderline.”

Dean Powell, whose leadership of the task force was already marred by reports that the co-chair she named, Dr. Leo Furcht, was sanctioned for violating the university’s old conflict of interest policies, will step down as medical school dean but continue to chair the ethics reform committee, according to the Daily.